Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2025-12-26 @ 4:42 AM
Study NCT ID:
NCT03745560
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2018-11-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intraoperative EABR for Decision Making
Sponsor:
Christoph Arnoldner
Organization:
Study Overview
Official Title:
Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.
Detailed Description:
Patients undergoing translabyrinthine vestibular schwannoma resection are included in the study. Preoperatively an eABR is carried out, as well as before and after tumor resection.
Postoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).
Postoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: